Director, Medical Devices & Combination Products

Director, Medical Devices & Combination Products

Field of work:
Regulatory & Medical

As Director, Medical Devices & Combination Products, you will shape global regulatory CMC strategy for our development and commercialized device combination products. You will translate governance decisions into actionable regulatory roadmaps that accelerate market access, support efficient submissions and approvals, and ensure compliance with FDA, EMA, EU MDR, and other applicable global standards.

• Develop, plan and execute global regulatory strategies for Drug Device Combination Products in development and during life‑cycle maintenance: ensuring alignment with FDA (21 CFR Parts 3/4/801/820), EMA/EC (EU MDR and Article 117), and relevant ISO standards.
• Authority engagement: lead and negotiate with FDA (including OCP), EMA/EC, Competent Authorities, and Notified Bodies; secure NB opinions and align on evidence requirements.
• Translate governance decisions into executable regulatory roadmaps with clear timelines, deliverables, and cross‑functional accountability across Development, Technical functions QA, Clinical Operation, and Commercial.
• Anticipate regulatory risks and opportunities. Develop evidence‑based scenarios and mitigations covering design controls, human factors validation, component/supplier changes, and CMC interfaces (extractables/leachable, drug–device compatibility, container closure integrity).
• Drive the strategy for evidence and data generation assessing the requirements for HF studies, biocompatibility matrices, sterilization validation, packaging/distribution validation, software documentation etc. Lead submission excellence and readiness across CMC for combination products to streamline reviews for global filings.
• Work with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Regulatory Affairs (GRA) for combination products.
• Provide regulatory leadership on Drug Device Combination product matters in cross‑functional teams, using your expertise in Devices and regulatory insight.
• Lead device‑specific labeling strategy and claims discussion.
• Establish regulatory intelligence initiatives, and policy shaping mechanisms, distilling external guidance into internal recommendations. Engage with Industry bodies to inform and shape policy.
• Collaborate with internal teams across development, Technical functions, QA, clinical, and commercial to streamline submissions and regulatory compliance.

• A Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, regulatory affairs, or a related field (an advanced degree is preferred).
• 12+ years of increasing responsibility in global regulatory affairs for Drug Device Combination Products with a proven track record in CMC/technical leadership.
• Expert knowledge of FDA, EMA/EC, EU MDR and global device/combination product regulations, standards, and pathways; deep familiarity with 21 CFR Parts 3/4/801/820; EMA Article 117 processes; NB opinion workflows.
• Advanced expertise across device standards and evidence: ISO 13485, ISO 14971, ISO 10993 series, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304; cybersecurity expectations; UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs).
• Proven leadership of Technical Files/Design Dossiers, PMA/510(k)/De Novo submissions, and integration of combination product requirements into NDA/BLA filings.
• Strong knowledge of CMC‑device interfaces, including extractables/leachables, drug‑device compatibility, and packaging/sterilization validations.
• Exceptional leadership and mentoring skills, with experience in capability building and establishing processes and frameworks for regulatory excellence.
• Strong communication and collaboration skills within cross functional teams. Skilled in negotiation and engagement with Agencies and Notified Bodies.
• Proven ability to navigate complex regulatory landscapes, anticipate risks, and influence senior governance decisions.

The base salary range for this position is $175,000‑240,000 per year. The base salary range represents the anticipated low and high of…